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QBG — Assay, Oral Direct Thrombin Inhibitor Class N

FDA Device Classification

FDA product code QBG covers "Assay, Oral Direct Thrombin Inhibitor", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code: QBG
Device Class: Class N
Regulation Number
Submission Type
Review Panel: HE
Medical Specialty: Unknown
Implant: No

Definition

An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma